The former Commissioner of the US Food and Drug Administration, Scott Gottlieb, this week claimed that the “CBD craze is out of hand”, and called for special rules to regulate the category.
Gottlieb, who stepped down as Commissioner in April, had previously been thought of as broadly sympathetic to the fledgling CBD product industry, signalling in early 2019 that the FDA would apply ‘enforcement discretion’ to the category. This was seen by many companies – specialist and non-specialist alike – as a green light for them to launch CBD products onto the US market.
Confusion over the legal status of CBD containing products stems largely from last December’s vote by Congress to lift a longstanding ban on hemp production.
What this didn’t do was change the law that prohibits putting hemp-derived CBD into foods and supplements, which remains in force.
Despite this, hundreds of CBD products have poured onto the market in the US in the last few months, making it of one fastest-growing ever natural health categories of all time.
Out of hand
Now, just weeks after suggesting that the FDA should consider a ‘light touch’ approach to CBD regulation, Scott Gottlieb has retuned to the debate with a controversial op-ed in the Washington Post proclaiming that “the CBD craze is out of hand”.
He writes: “Cannabidiol — better known as CBD — is everywhere, from small specialty shops to large national retail chains. It can be found in foods, supplements, drugs, oils, creams, pet foods and more, and sellers purport that the compound treats everything from cancer to depression. Analysts say the market could surpass $20 billion by 2024.”
“the Food and Drug Administration must act to make sure commercial interests don’t strip away any legitimate value that the compound might have”
In the piece, Gottlieb argues that many of the claims being made for CBD are “fanciful” and that “the Food and Drug Administration must act to make sure commercial interests don’t strip away any legitimate value that the compound might have”. And he points out that most CBD products on the market are illegal since federal law continues to prohibit putting CBD in food or pet food.
Toxicity risk
Gottlieb warns that CBD use carries cumulative toxicity risk – “if you eat CBD in your breakfast, lunch and dinner, you could get a toxic dose” – and that currently marketed products might also contain undeclared ingredients and impurities.
Gottlieb notes that “under current law, CBD is permitted in food or dietary supplements only if the FDA issues a regulation allowing its use”. This, he says, is “a multi-year process subject to notice and comment, requiring a substantial amount of scientific data that the FDA must evaluate”.
Gottlieb writes that “any path to allow CBD to be added to food products needs to preserve the incentive to study the compound in rigorous clinical trials to prove its therapeutic potential as a medicine,” adding that it would not be “appropriate or legal to make such claims otherwise”.
Pharma-first agenda
Gottlieb’s high profile re-intervention in the cannabidiol debate – in particular his comments about CBD’s “therapeutic potential as a medicine” – has raised concerns within the natural products industry that that FDA could be considering a regulatory process for CBD that is so onerous in its demands on manufacturers that only a few large players could achieve compliance.
“Laced through his piece are hints that betray a pharma-first agenda”
Voicing these concerns, Rick Polito, editor-in-chief at Nutrition Business Journal, wrote in response to Gottlieb’s cop-ed: “Laced through his piece are hints that betray a pharma-first agenda. He suggests the framework be ‘expressly unique to CBD’ to ward off ‘supplement makers seeking a back door to add other drugs to foods’. Does ‘other drugs’ mean Gottlieb is calling CBD a drug?”.